Study Summary
This trial will test an exercise intervention for secondary prevention of ADRD in adults at increased risk for ADRD. The rationale for this trial is the urgent need for dementia prevention.
Eligible Conditions
- Dementia
- Alzheimer's Disease
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 7 Secondary · Reporting Duration: Participants will be assessed at 6, 12 and 18 months.
Month 18
Change in Cognition Assessed by Neuropsychological Test Battery
Month 18
Change in Health behaviour with appropriate support strategies
Month 18
Change in Blood Biomarkers Assessed by Elisa Assays
Change in Brain Structure and Function Assessed by Neuroimaging Modalities
Change in Cerebral Blood Flow Assessed by Transcranial Doppler Ultrasound
Change in Maximal Oxygen Uptake (VO2max) Assessed by Metabolic Cart
Change in Risk/protective factors Assessed by Questionnaires
Change in Sleep Quality Assessed by Polysomnography, Actigraphy and Questionnaires
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
Aerobic exercise
1 of 1
Experimental Treatment
264 Total Participants · 1 Treatment Group
Primary Treatment: Aerobic exercise · No Placebo Group · N/A
Aerobic exercise
Behavioral
Experimental Group · 1 Intervention: Aerobic exercise · Intervention Types: BehavioralTreatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Aerobic exercise
2000
Completed Phase 2
~1080
Trial Logistics
Trial Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: participants will be assessed at 6, 12 and 18 months.
Who is running the clinical trial?
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,233 Previous Clinical Trials
24,676,388 Total Patients Enrolled
14 Trials studying Dementia
378,814 Patients Enrolled for Dementia
University of CalgaryLead Sponsor
706 Previous Clinical Trials
493,457 Total Patients Enrolled
5 Trials studying Dementia
1,073 Patients Enrolled for Dementia
Marc J Poulin, PhD, DPhilPrincipal InvestigatorUniversity of Calgary
3 Previous Clinical Trials
322 Total Patients Enrolled
Eligibility Criteria
Age 50 - 80 · All Participants · 10 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:You have one or more vascular risk factors for ADRD.
You are currently smoking.
You must provide a completed PAR-Q+ form (www.csep.ca), the standard method of obtaining physician approval for participation in an exercise program.
Subjects will be evaluated for subjective memory complaints using the MAC-Q Memory Complaint Questionnaire
References
- Krüger, Renata L., Cameron M. Clark, Adrienna M. Dyck, Todd J. Anderson, Fiona Clement, Patrick J. Hanly, Heather M. Hanson, et al.. 2021. “The Brain in Motion II Study: Study Protocol for a Randomized Controlled Trial of an Aerobic Exercise Intervention for Older Adults at Increased Risk of Dementia”. Trials. Springer Science and Business Media LLC. doi:10.1186/s13063-021-05336-z.
- Kruger RL, Clark CM, Dyck AM, Anderson TJ, Clement F, Hanly PJ, Hanson HM, Hill MD, Hogan DB, Holroyd-Leduc J, Longman RS, McDonough M, Pike GB, Rawling JM, Sajobi T, Poulin MJ. The Brain in Motion II Study: study protocol for a randomized controlled trial of an aerobic exercise intervention for older adults at increased risk of dementia. Trials. 2021 Jun 14;22(1):394. doi: 10.1186/s13063-021-05336-z.
- Marc Poulin 2017. "Aerobic Exercise for Older Adults at Increased Risk of Alzheimer's Disease and Related Dementias". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03035851.
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Conditions
Cancer Related
Treatments